A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

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This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125 (Fremanezumab) versus placebo in adult patients for the prevention of ECH.

the mean change from baseline (run-in period) in the weekly average number of cluster headache (CH) attacks during the 4-week period after administration of the first dose of the investigational medicinal product (IMP) [ Time Frame: Week 0 to 4 ]

Secondary Outcome Measures
:

the mean change from baseline in the number of CH attacks during the 4-week period after administration of the first dose [ Time Frame: Week 0 to 4 ]

the mean change from baseline in the number of CH attacks during the 12-week period after administration of the first dose [ Time Frame: Week 0 to 12 ]

the proportion of patients with a ≥50% reduction from baseline (run-in period) in the weekly average number of CH attacks during the 4-week period after the first dose of the IMP [ Time Frame: Week 0 to 4 ]

the mean change from baseline (run-in period) in the number of CH attacks during the 12-week period after administration of the first dose of the IMP [ Time Frame: Week 0 to 12 ]

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Ages Eligible for Study:

17 Years to 80 Years (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

The patient has a history of ECH according to the International Classification of Headache Disorders - 3 beta criteria (Headache Classification Committee of the IHS 2013) for ≥12 months prior to screening

The patient has a total body weight of ≥45 kg (99 lbs.)

The patient is in good health in the opinion of the investigator

Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study

Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must agree to use, together with their female partners, acceptable birth control

If a patient is receiving Botox, it should be in a stable dose regimen, considered as having ≥2 cycles of Botox prior to screening. The patient should not receive Botox during the run-in period up to the evaluation period (4 weeks) where the primary endpoint is evaluated.

Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

The patient has used systemic steroids for any medical reason (including treatment of the current CH cycle within ≤7 days prior to screening The patient has used an intervention/device (eg, scheduled nerve blocks) for headache during the 4 weeks prior to screening.

The patient has evidence or medical history of clinically significant psychiatric issues determined at the discretion of the investigator.

The patient has a past or current history of cancer or malignant tumor in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.

The patient is pregnant or lactating.

The patient has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies.

The patient has participated in a clinical study of a monoclonal antibody within 3 months or 5 half-lives before administration of the first dose of the IMP, whichever is longer, unless it is known that the patient received placebo during the study.

The patient has a history of prior exposure to a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway (AMG 334, ALD304, LY2951742, or fremanezumab). If patient has participated in a clinical study with any of these monoclonal antibodies, it has to be confirmed that the patient received placebo in order to be eligible for this study.

The patient is an employee of the sponsor/participating study center who is directly involved in the study or is the relative of such an employee.

The patient has an active implant for neurostimulation used in the treatment of CH.

The patient is a member of a vulnerable population (eg, people kept in detention).

The patient has a history of alcohol abuse prior to screening and/or drug abuse that in the investigator's opinion could interfere with the study evaluations or the patient's safety .

Additional criteria apply, please contact the investigator for more information